Skip to main content
OpenTrials
Completed

NCT Number: NCT00331526

Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells, including lymphokine-activated killer cells, to kill tumor cells. Giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells.

PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in treating patients with glioblastoma multiforme.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

About this study

OBJECTIVES:

  • Determine the feasibility, side effects, and toxicity associated with intracranial cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated killer cells in patients with glioblastoma multiforme.
  • Determine progression-free and overall survival of these patients.
  • Compare survival of these patients to that of contemporary and historical controls.

OUTLINE: Patients undergo therapeutic craniotomy.

Patients undergo leukapheresis to obtain lymphokine-activated killer (LAK) cells 3-7 days before therapeutic craniotomy OR 4-6 weeks after therapeutic craniotomy. Patients receive cellular adoptive immunotherapy comprising aldesleukin-stimulated LAK cells intracranially at the time of therapeutic craniotomy OR via an Ommaya reservoir (placed during craniotomy) no sooner than 4-6 weeks after therapeutic craniotomy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of primary malignant glioblastoma multiforme (i.e., grade IV anaplastic astrocytoma)
  • Primary treatment (surgery, radiation, and/or chemotherapy) has been completed
  • Candidate for surgery and willing to undergo craniotomy
  • No progressive or recurrent disease
  • No residual disease that requires reoperation, additional gamma therapy, or other modality

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% (i.e., if symptomatic, bedridden < half of a waking day)
  • Life expectancy ≥ 2 months
  • Not pregnant
  • Negative pregnancy test
  • U.S. residents only
  • No hematopoietic, hepatic, renal, cardiovascular, or pulmonary laboratory values or other medical circumstances that would preclude surgery or aldesleukin therapy
  • No serious concurrent medical or psychiatric illness that would preclude informed consent or study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior anticancer therapy and recovered
  • Prior stereotactic or gamma knife radiosurgery allowed

Treatment and study plan

aldesleukin

Biological

therapeutic autologous lymphocytes

Biological

adjuvant therapy

Procedure

conventional surgery

Procedure

Primary outcomes

  1. Side effects and toxicity

  2. Progression-free survival and overall survival

Sponsors and collaborators

Lead sponsor

Hoag Memorial Hospital Presbyterian

Other

Registry information

Official study title

Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes

Important dates

Study start
1999
Primary completion
2008
Study completion
2012
First posted
May 31, 2006
Registry last updated
Mar 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.